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How the serious shortages protocol will work, regardless of Brexit

David Reissner explains how the regulatory changes allowing pharmacies to dispense alternative medicines in the event of major shortages will work regardless of Brexit events

Medicines shortages have been much in the news and, following a short and informal consultation with pharmacies, the Department of Health and Social Care (DH) is changing the law from February 9 to allow an alternative prescription medicine to be supplied in certain circumstances. These circumstances are unrelated to Brexit.

Where a minister believes that there is a serious shortage of a specific prescription-only medicine (POM), the minister may issue a written serious shortage protocol (SSP) that provides for the sale or supply of either: a different strength, quantity or pharmaceutical form to that prescribed; or a different POM.

Protocols will be developed with and signed off centrally by clinicians. They may list what alternative products may be supplied by pharmacists without referring back to prescribers. Some products, for example, for the treatment of epilepsy, will not be covered by SSPs, and patients will have to be referred back to prescribers.

When a SSP has been issued, pharmacists will be freed from the legal requirement to supply only in accordance with a prescription, provided that they supply one of the following:

A generic equivalent of what has been prescribed

In the case of a biological medicinal product, a similar medicinal product

A therapeutically similar POM.

Any sale or supply under a SSP must be made by or under the supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that:

If a different strength, quantity or pharmaceutical form is supplied, it is reasonable and appropriate

If a different POM is supplied, it is reasonable to do so and the directions for use of the substituted product are appropriate.

Supplying an alternative POM without meeting the SSP conditions would involve the criminal offence of supplying otherwise than in accordance with a prescription.

If a patient is harmed by substitution, this is arguably an offence under section 64 of the Medicines Act 1968, but unless a pharmacist’s judgement has been shown to be flawed, the Crown Prosecution Service may decide that prosecution would not be in the public interest. Substitution will also be a breach of the NHS terms of service. Hopefully, NHS England will have the common sense not to take action, despite its poor track record for using common sense before issuing breach notices.

SSPs will have to be reviewed a year after issue and a stakeholder consultation will be conducted as part of the review.

The DH believes the main benefits of the protocol would be the NHS cost savings associated with GP time, but acknowledges that there may be some risks to patients. The DH expects that the impact on community pharmacies will be neutral: there will be cost savings through not having to liaise with GPs, but pharmacies will need to inform the GP when they dispense against a protocol. They may also be required to do further checks, which they would not do when dispensing against a prescription.

David Reissner is a consultant with law firm Charles Russell Speechlys LLP

Greg Lawton, Community pharmacist

Posted on Tue, 22/01/2019 - 19:18

"If a patient is harmed by substitution, this is arguably an offence under section 64 of the Medicines Act 1968"

Isn't the issue that any supply at all under an SSP would either be unlawful under Section 64 (if the supply is being made in pursuance of a prescription) OR it would be unlawful under the Human Medicines Regulations section 17 (if the government's argument is accepted that the supply is being made under an SSP and not a prescription)? It seems to me that this would be the case whether or not the patient is harmed? It might be unlawful under both acts due to the different wording ("in pursuance of" a prescription in the Medicines Act c.f. "in accordance with" a prescription in the Human Medicines Regulations found in the exemption in the MA section 10).

"Supplying an alternative POM without meeting the SSP conditions would involve the criminal offence of supplying otherwise than in accordance with a prescription."

That would mean that a deliberate decision to supply a different POM than permitted on the SSP was a breach of Section 64 of the Medicines Act (at least), and since it would have been deliberate, the new defences wouldn't apply.

Greg Lawton, Community pharmacist

Posted on Mon, 28/01/2019 - 16:31

My understanding having considered this further David, in light of this article and your reply, is:

Medicines Act

If the supply causes "prejudice" to the patient (e.g. harms them), it will be a breach of Section 64 of the Medicines Act. The arguments about thether it's supplied vs. an SSP or a prescription are irrelevant.

Human Medicines Regulations

Supplies under an SSP e.g. of an alternative POM/strength/quantity may be unlawful under Section 17, since the supply is not being made "in accordance with a prescription". The exemptions under Section 10 of the Medicines Act 1968 don't seem to be applicable.

https://www.legislation.gov.uk/ukpga/1968/67/section/10

Defences

The new defences to sections 63 and 64 of the Medicines Act will not apply.

C A, Community pharmacist

N patel , Non Pharmacist Branch Manager

Posted on Mon, 21/01/2019 - 20:52

oh pleeeease. .... how many times do you go out of your way to help a patient only to have it all thrown back at you......as for much needed funding......me thinks hell will freeze over first....pharmacists do things for free dont you know